From the Gut to the Strut: Reducing Inflammation for Healthy Muscles

NCT05730985 | Unknown

• 1 other identifier: 1206/01072022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This research aims to evaluate the effectiveness of a dietary supplement on reducing inflammation and improving muscle health. The product is a food supplement notified to the Ministry of Health consisting of: hydroxymethylbutyrate, carnosine, lactoferrin and magnesium, which help reduce inflammation and intestinal permeability and to improve muscle health.

Conditions

Inflammation; Sarcopenia; Gut Permeability

Outcome Measures

Primary Outcomes (10)

• Inflammation status

  A blood sample will be collected and analised for C-reactive protein and tumor necrosis factor alfa (TNF alfa)

  At the beginning of the treatment

• Inflammation status

  A blood sample will be collected and analised for C-reactive protein and tumor necrosis factor alfa (TNF alfa)

  After 4 months of treatment

• Muscle strength evaluation

  Muscle strength was measured by handgrip strength according to standard procedures by a hydraulic hand dynamometer (Jamar 5030 J1, Sammons Preston Rolyan, Bolingbrook, Canada with an accuracy of 0.6 N). The subject holds the dy-namometer in the hand to be tested, with the arm at right angles and the elbow by the side of the body, applying an isometric contraction

  At the beginning of the treatment

• Muscle strength evaluation

  Muscle strength was measured by handgrip strength according to standard procedures by a hydraulic hand dynamometer (Jamar 5030 J1, Sammons Preston Rolyan, Bolingbrook, Canada with an accuracy of 0.6 N). The subject holds the dy-namometer in the hand to be tested, with the arm at right angles and the elbow by the side of the body, applying an isometric contraction

  After 4 months of treatment

• body composition assessment

  Body composition represented by fat free mass and fat mass were measured using a Lunar Prodigy DXA (GE Medical Systems, WI, USA).

  At the beginning of the treatment

• body composition assessment

  Body composition represented by fat free mass and fat mass were measured using a Lunar Prodigy DXA (GE Medical Systems, WI, USA).

  After 4 months of treatment

• Physical performance assessment

  Physical performance was assessed using the Short Physical Performance battery test (SPPB) which comprised of gait speed, chair-stand test, and balance (three different tests that assess the ability to stand with the feet together in the side-by-side, semi-tandem, and tandem positions); each component was scored from 0 (not possible) to 4 (best performance) and the scores were added up to a total score ranging from 0 to 12.

  At the beginning of the treatment

• Physical performance assessment

  Physical performance was assessed using the Short Physical Performance battery test (SPPB) which comprised of gait speed, chair-stand test, and balance (three different tests that assess the ability to stand with the feet together in the side-by-side, semi-tandem, and tandem positions); each component was scored from 0 (not possible) to 4 (best performance) and the scores were added up to a total score ranging from 0 to 12.

  After 4 months of treatment

• Gut permeability.

  A blood sample will be collected and analised for indican

  At the beginning of the treatment

• Gut permeability.

  A blood sample will be collected and analised for indican

  After 4 months of treatment

Study Arms (2)

Intevention group

EXPERIMENTAL

Experimental formula (Miotrof®) to take 1 sachet per day for 4 months

Dietary Supplement: Miotrof® formula

Placebo group

PLACEBO COMPARATOR

Placebo formula to take 1 sachet per day for 4 months

Dietary Supplement: Placebo formula

Interventions

Miotrof® formula DIETARY_SUPPLEMENT

1 sachet per day for 4 months

Intevention group

Placebo formula DIETARY_SUPPLEMENT

1 sachet per day for 4 months

Placebo group

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• sarcopenic patients aged 55-85. Sarcopenia will be diagnosed according to the European Working Group on Sarcopenia in Older People (EWSGOP-2) criteria by muscle strength or chair stand test.

You may not qualify if:

• severe kidney disease (glomerular filtration rate \<30 mL/min),
• moderate-to-severe hepatic failure (Child-Pugh Class of B or C),
• endocrine diseases associated with disorders of calcium metabolism (with the exception of osteoporosis),
• psychiatric disorders,
• cancer (in the previous 5 years),
• hypersensitivity to any investigational food component
• subjects taking protein/amino acid supplements (up to 3 months prior to the study).
• patients not capable of taking oral therapy and those receiving or having indication for artificial nutrition or included in another clinical nutrition trial

Sponsors & Collaborators

• Azienda di Servizi alla Persona di Pavia: lead

Study Sites (1)

l'Istituto di Riabilitazione e cura "Santa Margherita" di Pavia, Azienda di Servizi alla Persona (ASP).

Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Inflammation; Sarcopenia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Central Study Contacts

Mariangela Rondanelli, MD

CONTACT

0382381739; mariangela.rondanelli@unipv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 16, 2023
• Study Start: October 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: September 30, 2023
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

IT (1)